The US Food and Drug Administration (FDA) “is responsible for protecting the public health by assuring the safety, efficacy, and security” of drugs and medical devices and for helping provide the public with the “science-based information” it needs to use drugs and devices to improve health.1 Under the current Code of Federal Regulations (CFR), new drug approval is typically based on demonstration of efficacy in 2 or more randomized clinical trials (RCTs), often in comparison with placebo; high-risk device approval appears to be based on considerably weaker evidence of safety and efficacy.2 Given the continued progress of science, approval of a new drug or device implies to physicians and the general public that the product represents an advance over older treatments.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 20
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.